Study Summary
This trial is studying if Fecal Microbiota Transplantation (FMT) can help reduce side effects from a cancer immunotherapy drug combination.
- Kidney Cancer
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
1 Primary · 7 Secondary · Reporting Duration: Approximately 9 years (end of study)
Trial Safety
Phase-Based Safety
Side Effects for
Awards & Highlights
Trial Design
1 Treatment Group
Fecal Microbiota Transplantation
1 of 1
Experimental Treatment
20 Total Participants · 1 Treatment Group
Primary Treatment: Fecal Microbiota Transplantation · No Placebo Group · Phase 1
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · All Participants · 2 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Eisenhauer, E.A., P. Therasse, J. Bogaerts, L.H. Schwartz, D. Sargent, R. Ford, J. Dancey, et al.. 2009. “New Response Evaluation Criteria in Solid Tumours: Revised RECIST Guideline (version 1.1)”. European Journal of Cancer. Elsevier BV. doi:10.1016/j.ejca.2008.10.026.
- Ninkov M, Schmerk CL, Moradizadeh M, Parvathy SN, Figueredo R, Burton JP, Silverman MS, Fernandes R, Maleki Vareki S, Haeryfar SMM. Improved MAIT cell functions following fecal microbiota transplantation for metastatic renal cell carcinoma. Cancer Immunol Immunother. 2022 Nov 18. doi: 10.1007/s00262-022-03329-8. [Epub ahead of print]
- Ninkov M, Schmerk CL, Moradizadeh M, Parvathy SN, Figueredo R, Burton JP, Silverman MS, Fernandes R, Maleki Vareki S, Haeryfar SMM. Improved MAIT cell functions following fecal microbiota transplantation for metastatic renal cell carcinoma. Cancer Immunol Immunother. 2022 Nov 18:1-14. doi: 10.1007/s00262-022-03329-8. Online ahead of print.
- Ninkov M, Schmerk CL, Moradizadeh M, Parvathy SN, Figueredo R, Burton JP, Silverman MS, Fernandes R, Maleki Vareki S, Haeryfar SMM. Improved MAIT cell functions following fecal microbiota transplantation for metastatic renal cell carcinoma. Cancer Immunol Immunother. 2023 May;72(5):1247-1260. doi: 10.1007/s00262-022-03329-8. Epub 2022 Nov 18.
- 2020. "Preventing Toxicity in Renal Cancer Patients Treated With Immunotherapy Using Fecal Microbiota Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04163289.
Frequently Asked Questions
What is the total enrollment figure for this clinical investigation?
"Affirmative. Clinicaltrials.gov data indicates that this experiment, which was first made public on January 23rd 2020, is actively enrolling participants. 20 patients need to be enrolled at a single site." - Anonymous Online Contributor
Is there capacity available to include more participants in this research endeavor?
"Affirmative, the information available on clinicaltrials.gov indicates that a recruitment drive for this trial is underway. It was posted online on January 23rd 2020 and edited most recently in April 5th 2022; 20 volunteers are required from one single medical site." - Anonymous Online Contributor
Is Fecal Microbiota Transplantation a viable and secure therapy for patients?
"As Fecal Microbiota Transplantation is currently in its preliminary stages of research, with limited data supporting safety and efficacy; it has earned a rating of 1." - Anonymous Online Contributor